European Medicines Agency prepares for approval of pandemic vaccines

Press release 30/04/2009

The European Medicines Agency, together with its partners in the EU Member States, the European Commission, the European Centre for Disease Prevention and Control (ECDC), the World Health Organization (WHO) and the European Directorate for the Quality of medicines and healthcare (EDQM) met today with vaccine manufacturers. The purpose of the meeting was to share information on the novel influenza virus and discuss regulatory and scientific issues concerning the development and eventual approval of vaccines for use in a pandemic situation. Any decision on a strategy for development of pandemic vaccines will depend on recommendations from the WHO.

The Agency has been preparing for a pandemic scenario since 2004. Working closely with its partners in the European Union, it has established a scientific and regulatory framework that can accommodate a range of different vaccine approval strategies.

There are currently six centrally approved marketing authorisations for vaccines, four of them specifically designed to be modified rapidly to incorporate a new pandemic strain, once it has been recommended by the WHO. However, it may take four to six months before initial doses of vaccine are available.
Until a vaccine becomes available, antiviral medicines can be used for the treatment of pandemic influenza cases. Member States have prepared emergency plans, which also include how antivirals will be made available to citizens. The neuraminidase inhibitors Tamiflu (oseltamivir) and Relenza (zanamivir) have shown effectiveness against the novel flu virus.

While the European Medicines Agency, together with the European Commission, is responsible for the authorisation and supervision of centrally authorised medicines, decisions on availability and distribution of medicines within their territories are taken by each European Member State in accordance with their national pandemic plans.

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